Healthcare Industry News:  ventilator 

Diagnostics FDA

 News Release - March 31, 2010

Abbott Submits Test to Aid in Identifying Patients at Risk of Developing Kidney Injury

ABBOTT PARK, Ill., March 31 (Healthcare Sales & Marketing Network) -- A novel diagnostic test to rapidly detect neutrophil gelatinase-associated lipocalin (NGAL), an early biomarker that identifies patients at risk for acute kidney injury (AKI), has been accepted for review by the United States Food and Drug Administration. If approved, this would be the first test available for use in the United States for the detection of NGAL.

"With the help of a new diagnostic test that can aid in detecting NGAL, physicians can significantly reduce the risk of AKI by using simple measures such as hydration or blood pressure support to lower the risk of harm," said Sudarshan Hebbar, M.D., medical director, Abbott Diagnostics.

Abbott's test would be able to detect NGAL about two days earlier than the most widely used method for the detection of AKI, a serum creatinine blood test. A landmark study published in Annals of Internal Medicine in May 2008, reported that NGAL is a highly sensitive and specific test for differential diagnosis of AKI that helps distinguish acute injury from normal function and chronic kidney disease.

"From the single drop of urine, we obtain vital information when time is critical to improve patient management. Early information provided by an NGAL urine test could make treatments more timely and effective and reduce costs due to early intervention," said Dr. Hebbar.

The new Abbott test received CE Mark certification in Europe last year and is being used by nephrologists and other physicians in the European Union. It is currently an investigational device in the United States. Abbott's Urine NGAL assay is performed on the company's flagship automated laboratory instrument, the ARCHITECT system.

About Acute Kidney Injury

AKI is a common and often devastating illness that quickly reduces the ability of the kidneys to filter waste, a condition which can then progress to kidney failure. Common causes of AKI include sepsis, major surgery, cardiogenic shock, trauma and medications toxic to the kidneys. Onset of AKI is swift. Prompt diagnosis of AKI is critical in reducing mortality, which is as high as 80 percent in post-operative settings. In addition, AKI predisposes those surviving to an increased incidence of chronic kidney disease and end-stage renal disease. Studies show the incidence of AKI has risen 11 percent in recent years, prompting physicians to seek better ways to diagnose and treat this condition. In the United States, it is estimated that $10 billion per year is spent to treat AKI. Costs associated with AKI in hospitalized patients are linked with increases in the length of intensive care unit days, prolonged hospital stays, ventilator use, and overall treatment cost.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. The history of Abbott is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.

About Abbott

Abbott (NYSE:ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.


Source: Abbott

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